Recruiting
Phase 1
Phase 2

ALE.P03

Sponsor:

Alentis Therapeutics AG

Code:

NCT07169734

Conditions

Cervical Squamous Cell Carcinoma

Squamous Non-small-cell Lung Cancer

Colorectal Cancer

Intrahepatic Cholangiocarcinoma

Urothelial Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ALE.P03

ALE.P03

ALE.P03

Study Details

Brief summary:

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P03 monotherapy in adult patients with selected squamous solid tumors.

Conditions

Cervical Squamous Cell Carcinoma

Squamous Non-small-cell Lung Cancer

Colorectal Cancer

Intrahepatic Cholangiocarcinoma

Urothelial Carcinoma

Study ID

NCT07169734

Start date

Aug 26, 2025

Status verified date

Sep, 2025

Completion date

Oct 4, 2029

Anticipated

Primary completion date

Apr 5, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Have histologically and cytologically metastatic confirmed advanced or metastatic colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, and cervical squamous cell carcinoma.
  • Have documented radiological disease progression at study entry.
  • Have provided tissue for CLDN1 (Claudin-1) analysis in a central laboratory.

Phase I Dose Escalation:

\- Received and being refractory/intolerant to available systemic standard of care (SOC) regimens (based on local institutional guidelines) for advanced disease.

Phase I RDE and Phase II:

  • Received 1-2 available systemic SOC regimens (based on local institutional guidelines) for advanced disease and being refractory or intolerant to treatment.
  • Patients with actionable oncogenic drivers: received feasible targeted therapy.

Applicable for Phase I Dose Escalation, Phase I RDE and Phase II:

  • Measurable disease per RECIST 1.1, as determined by the site.
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Groups Performance Status.
  • Demonstrate adequate bone marrow and organ function as per the protocol.

Exclusion Criteria:

  • SqNSCLC and CSCC: diagnosed with a tumor of predominantly non-squamous histology result or adenocarcinoma.
  • Has received antineoplastic therapies prior to study intervention within specified time frame.
  • Has rapidly progressing disease.
  • Has known active central nervous system metastases and/or carcinomatous meningitis.
  • Has a history of (non-infectious) interstitial lung disease/pneumonitis that required steroids or current symptomatic or clinically significant pneumonitis requiring steroids and/or immunosuppressive therapies.
  • Has clinically significant gastrointestinal bleeding.
  • Has an active infection requiring systemic treatment.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase I Dose Escalation- ALE.P03

Patients will receive ALE.P03 as monotherapy via intravenous infusion. The ALE.P03 will be given at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended dose for expansion (RDE) is determined in Phase I dose escalation part of the study.

experimental: Phase I Dose Expansion- ALE.P03

Patients will receive ALE.P03 as monotherapy via intravenous infusion. The safe recommended doses of ALE.P03 will be given in Phase I dose expansion part of the study to identify recommended Phase II dose (RP2D) for Phase II.

experimental: Phase II- ALE.P03

Patients will receive ALE.P03 as monotherapy via intravenous infusion at the RP2D, or according to the dosing schedule after the dose expansion phase.

Interventions

ALE.P03

ALE.P03, will be administered by IV infusion according to the assigned arms.

ALE.P03

ALE.P03, will be administered by IV infusion according to the assigned arms.

ALE.P03

ALE.P03, will be administered by IV infusion according to the assigned arms.

Primary outcome measure

  • Number of Patients with Dose Limiting Toxicities (DLTs) (Phase I) [ Time Frame: Up to 28 days ]
  • Number of Patients with Adverse Events (Phase I) [ Time Frame: From Day 1 up to Safety follow-up (30 ± 5 days post last dose [Up to 4 years]) ]
  • Overall Response Rate (ORR) (Phase I) [ Time Frame: From ALE.P03 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 4 years) ]
  • Duration of Response (DoR) (Phase I) [ Time Frame: From ALE.P03 treatment initiation until disease progression or study completion (Up to 4 years) ]
  • Overall Response Rate (ORR) (Phase II) [ Time Frame: From ALE.P03 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 4 years) ]
  • Duration of Response (DoR) (Phase II) [ Time Frame: From ALE.P03 treatment initiation until disease progression or study completion (Up to 4 years) ]

Central Contacts and Locations

Central contacts

Alentis Clinical Trial Contact

+41782304288patientinfo@alentis.ch

Locations

Mayo Clinic Comprehensive Cancer Center

Recruiting

Phoenix, Arizona, United States, 85054

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Yale Comprehensive Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

The University of Chicago Medical Center - Oncology

Recruiting

Chicago, Illinois, United States, 60637

Principal Investigator:

Principal Investigator

Norton Cancer Institute - Norton Healthcare Pavilion

Recruiting

Louisville, Kentucky, United States, 40202

John Theurer Cancer Center

Recruiting

Hackensack, New Jersey, United States, 07601

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Next Oncology-Oncology

Recruiting

San Antonio, Texas, United States, 78229

NEXT Oncology Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Alentis Therapeutics AG

Last update posted

Jul 2, 2026

Last verified

Sep, 2025

Keywords

  • Claudin-1 Targeted Antibody-Drug Conjugate
  • Monotherapy
  • First-in-Human
  • Recommended Phase 2 dose
  • Recommended dose for expansion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Alentis Therapeutics AG on 2026-07-02.